Abstract
HIV infection is an exclusion criterion in lung cancer trials. This multicentre phase II trial aimed to assess feasibility, efficacy and safety of first-line carboplatin plus pemetrexed (CaP) followed by pemetrexed (P) maintenance in people living with HIV (PLHIV) with advanced non-squamous non-small cell lung cancer (NS-NSCLC).
Four cycles of CaP were followed by P-maintenance therapy in patients with Eastern Cooperative Oncology Group performance status ≤2. The primary objective was a disease control rate (DCR) ≥30% after 12 weeks.
Of the 61 PLHIV enrolled, 49 (80%) had a performance status of 0–1, and 19 (31%) had brain metastases. Median CD4 lymphocyte count was 418 cells·µL−1 (range 18–1230), median CD4 lymphocyte nadir was 169.5 cells·µL−1 (1–822); 48 (80%) patients were virologically controlled. Four-cycle inductions were achieved by 38 (62%) patients, and 31 (51%) started P-maintenance (median of 4.1 cycles (range 1–19)). The 12-week DCR was 50.8% (95% CI 38.3–63.4) and partial response rate 21.3%. Median progression-free survival and overall survival were 3.5 (95% CI 2.7–4.4) and 7.6 months (5.7–12.8), respectively. Patients with a performance status of 0–1 had the longest median progression-free survival (4.3 months, 95% CI 3.1–5.2) and overall survival (11.9 months, 95% CI 6.4–14.3). During induction, CaP doublet was well tolerated apart from grade 3–4 haematological toxicities (neutropenia 53.8%; thrombocytopenia 35.0%; anaemia 30.0%). Two fatal treatment-related sepses were reported. No opportunistic infections were experienced.
In PLHIV with advanced NS-NSCLC, first-line four-cycle CaP induction followed by P-maintenance was effective and reasonably well-tolerated. Further studies should evaluate combination strategies of CaP with immunotherapy in PLHIV.
Abstract
In this first clinical trial dedicated to people living with HIV and advanced non-squamous non-small cell lung cancer, first-line 4-cycle carboplatin plus pemetrexed followed by pemetrexed maintenance chemotherapy was effective and reasonably well-tolerated https://bit.ly/2xAqeEl
Footnotes
This article has supplementary material available from erj.ersjournals.com
Author contributions: Conception and design: A. Lavolé, L. Greiller, J. Mazières, I. Monnet, L. Kiakouama-Maleka, X. Quantin, J.P. Spano, H. Lena, P. Fraisse, H. Janicot, C. Audigier-Valette, A. Langlais, F. Morin, A. Makinson and J. Cadranel; financial support: F. Morin; administrative support: F. Morin; provision of study material or patients: A. Lavolé, L. Greiller, J. Mazières, I. Monnet, L. Kiakouama-Maleka, X. Quantin, J.P. Spano, H. Lena, P. Fraisse, H. Janicot, C. Audigier-Valette and J. Cadranel; collection and assembly of data: A. Lavolé, A. Langlais, F. Morin, A. Makinson and J. Cadranel; data analysis and interpretation: A. Lavolé, J. Mazières, A. Langlais, F. Morin, A. Makinson and J. Cadranel; manuscript writing: all authors; final approval of manuscript: all authors; accountable for all aspects of the work: all authors.
Conflict of interest: A. Lavole has nothing to disclose.
Conflict of interest: L. Greillier reports personal fees from AstraZeneca, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, MSD, Takeda, Abbvie and Novartis, outside the submitted work; travel and accommodation expenses from MSD and Pfizer.
Conflict of interest: J. Mazières has nothing to disclose.
Conflict of interest: I. Monnet has nothing to disclose.
Conflict of interest: L. Kiakouama-Maleka has nothing to disclose.
Conflict of interest: X. Quantin has nothing to disclose.
Conflict of interest: J.P. Spano reports personal fees for consultancy from MSD, Roche and Biogaran, personal fees for advisory board work from Lilly, Mylan and Novartis, personal fees for advisory board work and lectures from Pfizer and Leopharma, personal fees for lectures from Pierre Fabre Oncology, AstraZeneca and Gilead, grants from BMS and MSD Avenir, outside the submitted work.
Conflict of interest: H. Lena has nothing to disclose.
Conflict of interest: P. Fraisse has nothing to disclose.
Conflict of interest: H. Janicot has nothing to disclose.
Conflict of interest: C. Audigier-Valette has nothing to disclose.
Conflict of interest: A. Langlais has nothing to disclose.
Conflict of interest: F. Morin has nothing to disclose.
Conflict of interest: A. Makinson has nothing to disclose.
Conflict of interest: J. Cadranel reports grants from AstraZeneca, Novartis and Pfizer, outside the submitted work.
Support statement: Lilly (France) supplied pemetrexed and a research grant to Intergroupe Francophone de Cancérologie Thoracique (IFCT) for the IFCT-1001 CHIVA Trial. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received October 22, 2019.
- Accepted April 15, 2020.
- Copyright ©ERS 2020
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